A Breathing-Based Meditation Intervention for Patients With Treatment-Resistant Late Life Depression (TR-LLD): A Phase II Trial and Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Severity of TR-LLD as measured by the Hamilton Depression Scale (HAM-D17).
研究概览
简要总结
Late-life depression affects 2-8% of seniors and causes high rates of caregiver distress and risk of suicide. To exacerbate the problem, antidepressants, the cornerstone of therapy, are resistant in 55-80% of this population. Hence, this group of patients is labeled as having treatment-resistant late-life depression (TR-LLD).
Non-pharmacological interventions like meditation could offer significant benefits as augmentation strategies to improve response rate of antidepressants in TR-LLD. One such breath-based meditation intervention called Sudarshan Kriya Yoga is of interest based on highly significant preliminary data in adult patients with treatment-resistant depression, its scalability and relatively low cost to learn this lifelong skill.
Thirty patients diagnosed with TR-LLD will learn this intervention over 5 consecutive days by a certified para-professional trainer. This will be followed by 3 weekly 90 min follow-up sessions and then bimonthly sessions for 8 more weeks. SKY consists of a series of breathing techniques, including Sudarshan Kriya (SK), a sequential rhythm-specific breathing exercise. Participants will be asked to practice this technique for 25-30 minutes daily over the next 11 weeks. The investigators will collect clinical as well as feasibility outcome measures. The investigators will also explore if it is feasible to assess the antioxidant Glutathione (GSH) in the brain using a sophisticated magnetic resonance spectroscopy. The investigators suspect that GSH levels are reduced in TR-LLD and they will improve with SKY.
详细描述
RECRUITMENT AND CONSENT:
Patients will be recruited from Victoria Hospital, London Health Sciences Centre or Parkwood Mental Health, St. Joseph's Health Care London. Patients will be screened and recruited after giving valid consent.
STUDY INTERVENTION (Sudarshan Kriya Yoga, SKY):
The 30 recruited TR-LLD participants will be invited to attend training sessions on SKY. The SKY program is a highly structured and standardized mind-body resilience building program. Through SKY breathing, interactive discussions, journaling, yoga and guided meditations, the workshop builds a framework for resilience and empowerment, and develops self-awareness, connectedness and community, and a positive outlook. This is a minimally invasive treatment and is not routinely available as standard of care. SKY involves rhythmic, cyclical forms of breathing in which there are no pauses between inhalation and exhalation. The breathing practices of this program include: (a) a three-stage Pranayama with Ujjayi, also called Victory Breath or Ocean Breath (b) Bhastrika or Bellow's Breath and (c) Sudarshan Kriya (SK) or the Rhythmic Breath Technique.
SKY will be consistently taught to the participants by two instructors from The Art of Living Foundation, an international humanitarian and charitable organization. SKY training will take place in a group-format with group sizes varying between 4-6 participants. The investigators will conduct these training sessions in an appropriately sized and accessible community hall in London, Ontario. SKY training involves attending a 5-day course that teaches the basic principles of SKY over 2.5-3 hour daily sessions. These will be followed by once weekly follow up sessions (90 min/wk) for 3 weeks and then bimonthly sessions (every 2 weeks) for the next 8 weeks. In addition, participants will be asked to practice SKY at home daily (25 min/day) throughout the duration of the study period and log practice frequency and any other noteworthy observations in a log sheet that will be provided to them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60-80 years of age
- •major depressive disorder, as per the results of an interview by a trained rater using the Structured Clinical Interview for DSM-5 and subsequently confirmed by the psychiatrist
- •Mild to moderate depression as confirmed by a score on the HAM-D 17 between 8 and 23
- •Have failed at least two trials of antidepressants, given at adequate doses for adequate duration during the current episode
- •Able to follow verbal instructions and sit without physical discomfort for 45 minutes
- •Willing and able to attend at least 75% of all Sudarshan Kriya Yoga (SKY) sessions
- •Willing to dedicate 25-30 minutes/day to SKY practice at home
- •Low risk of suicide based on a clinical initial interview and during follow-up interviews at weeks 4, 8 and 12.
排除标准
- •Uncontrolled hypertension, seizure disorder, psychosis, substance abuse, or dementia
- •Currently participating in other similar studies or currently practicing any type of formal meditation, mindfulness or breathing techniques
- •A major surgery within 6 weeks prior to commencement of or scheduled during, the study intervention
- •A traumatic brain injury
- •Any contraindications to MRI will also be excluded
- •Healthy control participants must have no significant mental health issues, or contraindications to MRI.
研究组 & 干预措施
Sudarshan Kriya Yoga
Thirty participants with treatment-resistant late life depression (TR-LLD) will attend 5 instructional days of Sudarshan Kriya Yoga (SKY), followed by 3 weekly follow-ups, and 8 weeks of bimonthly follow-ups. Participants will also practice SKY for 25 minutes per day at home. These participants will attend 4 mental health assessments at weeks 0, 4, 8, and 12. Thirteen of the recruited TR-LLD will attend an MRI at baseline and post-intervention.
干预措施: Sudarshan Kriya Yoga (Other)
Control
The seven recruited age-matched controls will complete a screening appointment and an MRI only for comparison. Demographic information will also be collected from the control participants. These individuals will not undergo the study intervention.
结局指标
主要结局
Severity of TR-LLD as measured by the Hamilton Depression Scale (HAM-D17).
时间窗: 12 weeks
The primary outcome measure will be the Hamilton Depression Rating Scale (HAM-D 17) score. The HAM-D17 rates symptoms commonly associated with Major Depressive Disorder (MDD). A total score is calculated based on the first 17 questions of the HAM-D with a score range of 0 to 53. A higher score indicates more severe depression, and a lower score indicates fewer and/or less severe symptoms of depression.
次要结局
- Glutathione levels measured by a 7-Tesla Magnetic Resonance Imaging (7T-MRI) in TR-LLD.(12 weeks)
- Caregiver burden in caregivers of TR-LLD as measured by the Zaritz Caregiver Burden scale.(12 weeks)
- Quality of Life of TR-LLD participants using the European Quality of Life (EQ-5D-5L) scale.(12 weeks)
- Anxiety severity of TR-LLD participants measured by the Geriatric Anxiety Inventory (GAI).(12 weeks.)
研究者
Akshya Vasudev
MBBS, MD, MRCPsych, PG Cert Medical Education Associate Professor of Psychiatry and Medicine, Western University Consultant Geriatric Psychiatrist, London Health Sciences Centre
Lawson Health Research Institute